The following data is part of a premarket notification filed by Metron U.s., Inc. with the FDA for Ps-41 6m Patient Simulator.
| Device ID | K963198 |
| 510k Number | K963198 |
| Device Name: | PS-41 6M PATIENT SIMULATOR |
| Classification | Electrocardiograph |
| Applicant | METRON U.S., INC. 1345 MONROE, N.W., #255A Grand Rapids, MI 49505 |
| Contact | Jim Quinn |
| Correspondent | Jim Quinn METRON U.S., INC. 1345 MONROE, N.W., #255A Grand Rapids, MI 49505 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-15 |
| Decision Date | 1997-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850540007171 | K963198 | 000 |